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Lise Stevens is Associate Director at Iperion Life Sciences Consultancy in Rockville, Maryland in the US. She is a specialist in project management, IDMP and ICSR training and implementation. Iperion, which operates globally, is paving the way to digital healthcare through its proactive support for standardization and by ensuring the right technology, systems and processes are in place to facilitate process innovation.
Lise Stevens explores what difference the ISO IDMP (Identification of Medicinal Products) data standards would have made in a COVID-19 context — in applications ranging from pharmacovigilance adverse event reporting and electronic prescribing to falsified medicines control.
The ISO IDMP (Identification of Medicinal Products) data standards are designed to support reliable, efficient sharing of information about medicines internationally. Lise Stevens explores what difference the standards would have made in a COVID-19 context — in applications ranging from pharmacovigilance adverse event reporting and electronic prescribing to falsified medicines control.
Sometimes it takes a crisis to focus minds on what’s important and what needs to happen, and this certainly applies in relation to ISO IDMP (Identification of Medicinal Products) standards adoption. Imagine if ISO IDMP had already been implemented and was now in general use. We would already have a global substance ID, and the generic Pharmaceutical Product Identifiers (PhPIDs) needed to link adverse event reports from clinical trials around the world would be possible. With manufacturers, regulators and clinicians agreed on consistent representation and description of the various attributes of a drug, a common learning health system could provide the needed real-world evidence (RWE) about how well (or not) novel or expanded use of existing products are performing at the point of care. Drug safety and efficacy monitoring could be near real time, too, especially if medication alerts —informed by IDMP data exchange — and automated adverse event (AE) reporting were in place.
Consistent representation of product information at the investigational stage could help support data sharing among researchers, and potentially bolster study enrollment efforts using information stored in electronic health records (EHRs). For example, Specified Substance Group (SSG) Identifiers1 would be extremely valuable for Investigational New Drug (IND) safety reporting, especially in cases where different manufacturers are developing the same or similar products intended for immediate or expanded use. The safety or efficacy profile could vary by product — based upon source material, production process or impurities used to manufacture a product.
The ability to share and integrate this data by clinical researchers and global regulators could help inform needed changes to trial protocols in order to reduce AE risk exposure, or suggest increased monitoring of certain symptoms. It is important to note that product identifiers are linked throughout the product lifecycle. The IDMP Medicinal Product Identifier (MPID) is intended as a globally unique ID used to distinguish the same product approved for use in various markets. This identifier is linked to PhPIDs, package IDs and the Global Trade Item Number (GTIN), which may also include batch and expiration date information. The links between the IDs is vital for combating the threat of falsified medicines entering supply chains, especially in under-served populations.
The linking of IDMP and GTIN identifiers across country boundaries enriches clinical decision support and improves e-prescribing/pharmacy information systems, because it becomes much easier to compare formulations and identify potential equivalents. This information helps healthcare providers and patients make more informed decisions and gauge the availability of products while traveling. This is important in cases where the use of equivalent or alternative products is warranted due to unwanted side effects. Medication safety alerts or drug shortage information would become easier to disseminate, especially if regulators, industry and clinicians could agree on consistent data exchange at the appropriate level. For example, the detail needed for regulatory approval may not be necessary to support a patient monitoring program or mobile consumer application (app). Warnings about product problems or shortages could be pushed to pharmacy systems and consumer apps in real time.
Instead of aiming for these desirable scenarios, we are slowly implementing IDMP based upon regulatory compliance. It is time to flip the paradigm and begin with the end in mind — which is patient access to reliable and accurate product information, especially during a pandemic or bioterrorism crisis.
IDMP is about improving regulatory processes and leveraging commonly-understood data for the advancement of healthcare. In the continuing pandemic, everyone is learning as they go and (ideally) feeding into a common knowledge pool: a learning health system which is expanding all the time, in turn informing healthcare processes and potentially transforming patient outcomes. A pre-requisite for knowledge sharing is the creation of structured, high-quality data updated in real time. Then translational research tools could have quicker access to credible data sets to draw important conclusions, and improve regulatory and clinical decision-making.
It is keeping real-world end goals in mind that will drive the next push to make IDMP a reality. But everyone needs to buy into this, and approach next developments with a shared sense of urgency.
ISO IDMP implementations are slow, divergent and the underlying data exchange standards are outdated given advances in cloud-based technologies. Unless stakeholders globally concede some ground and work together to harmonies requirements and prove the standards, the intended benefits of IDMP will never become a reality.
Failure to resolve the final details of IDMP exchange and harmonization will continue to impede creation of optimized IT systems and integration with healthcare and patient apps. This is enormously frustrating when there is such urgency around meaningful progress in life sciences linked to the current pandemic. For IDMP to fulfil its wider purpose, stakeholders around the world must view COVID-19 as a driver for more targeted and proactive harmonization across the geographical regions. It must not take a new, future pandemic or bioterrorist event to deliver what has been promised for years. We need those benefits now.
Success today, while it counts, will depend on a concerted effort to secure progress — in place of siloed decision-making among regions.
These are uncertain times, but sometimes it takes a crisis to focus attention and resources. A consortium approach to driving real change will be the most effective going forward. There needs to be a greater push and some proactive negotiation from the pharmaceutical industry now, for instance, so that the regulators and healthcare providers can see their commitment for an international framework where everyone has a seat at the table, to advocate for real-world solutions on behalf of patients. Academic researchers should be party to discussions too, promoting the role of a robust learning health system and what will be needed to advance this.
Yes, these are challenging times, but sometimes it takes dramatic circumstances to prompt the right degree of change.
1 . Per ISO 11238, a substance can be specified (defined) at greater levels of specificity based upon additional information, such as purity or grade, manufacturing process, constituent substances and potency